FDA Device recall Z-2124-2012
IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074
- FDA Device
- Class III
- terminated
- Published 2012-08-08
On 2012-08-08 the FDA classified a Class III recall of IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074 by Iris Diagnostics, citing the firm recalled after it received complaints of IRISpec CA/CB two part Urine Chemistry Control, 101131-12, where the nitrite results read negative for the part B control, which….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2124-2012 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-07-09 |
| Published | 2012-08-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Iris Diagnostics |
| Distribution | US |
Product
IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074. Intended Use: IRISpec CA/CB is an assayed QC material for monitoring of the urine chemistry analytes and devices as listed on the package insert. For in vitro diagnostic (IVD) use only.
Reason
The firm recalled after it received complaints of IRISpec CA/CB two part Urine Chemistry Control, 101131-12, where the nitrite results read negative for the part B control, which should be positive.
Identifiers
| code_info | Iris Diagnostics part number 800-0074, lot number 131-12. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2124-2012%22
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